Warning Letters

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

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Letters with Response or Closeout

Posted Date

Year

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
08/01/2023	07/28/2023	Intas Pharmaceuticals Limited	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/13/2023	Jamol Laboratories, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	06/21/2023	Porfirios Italian Foods, Inc.	Division of Human and Animal Food Operations East II	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
08/01/2023	07/18/2023	Avlon Industries, Inc.	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/25/2023	Centaur Pharmaceuticals Private Ltd.	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/25/2023	Baxter Healthcare Corporation	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/20/2023	Iso-Tex Diagnostics, Inc.	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/17/2023	LXR Biotech, LLC	Division of Pharmaceutical Quality Operations III	CGMP/Finished Pharmaceuticals/Adulterated
08/01/2023	07/19/2023	La Yongjia Trade Co.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
08/01/2023	07/14/2023	Premier Food Supplies LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)